• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

      Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

      CRISPR Combined with Glowing Proteins for Viral Detection

      CRISPR Combined with Glowing Proteins for Viral Detection

      Biomimetic Construct Models Burn Injuries

      Biomimetic Construct Models Burn Injuries

      Moving Cells Using Ultrasound

      Moving Cells Using Ultrasound

    • Radiology
      Imaging Technique Reveals Contraction Patterns During Labor

      Imaging Technique Reveals Contraction Patterns During Labor

      Moving Cells Using Ultrasound

      Moving Cells Using Ultrasound

      Ultrasound Catheter to Treat Hypertension

      Ultrasound Catheter to Treat Hypertension

      Antibacterial Smart Sutures Visible in CT Scans

      Antibacterial Smart Sutures Visible in CT Scans

    • Cardiology
      Scientists Grow Electrodes Inside The Body

      Scientists Grow Electrodes Inside The Body

      Patient-Specific Soft Robotic Heart Replicas for Treatment Planning

      Patient-Specific Soft Robotic Heart Replicas for Treatment Planning

      Tiny Patch for Cardiac Ultrasound Imaging

      Tiny Patch for Cardiac Ultrasound Imaging

      Belt Monitors Heart Failure Patients

      Belt Monitors Heart Failure Patients

    • Surgery
      Biomimetic Construct Models Burn Injuries

      Biomimetic Construct Models Burn Injuries

      Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

      Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

      Self-Assembling Peptides as a Bioink

      Self-Assembling Peptides as a Bioink

      3D Bioengineered Skin Grafts Fit Complex Anatomy

      3D Bioengineered Skin Grafts Fit Complex Anatomy

    • Nanomedicine
      Bottlebrush Particle for Synergistic Drug Combinations

      Bottlebrush Particle for Synergistic Drug Combinations

      Extra Hot Nanoparticles for Cancer Therapy

      Extra Hot Nanoparticles for Cancer Therapy

      Making Tumors Tastier for the Immune System

      Making Tumors Tastier for the Immune System

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Improved Membrane Coating for Anti-Cancer Nanoparticles

    • Military Medicine
      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fabric Makes Electricity from Movement to Power Wearables

      Fabric Makes Electricity from Movement to Power Wearables

      Wearable Uses Microneedles to Track Metabolism

      Wearable Uses Microneedles to Track Metabolism

    • Rehab
      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Non-Invasive Spinal Modulation for Cerebral Palsy

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

Pelvalon’s Eclipse Vaginal Insert for Fecal Incontinence FDA Approved

February 18th, 2015 Medgadget Editors GI, News, Ob/Gyn

Pelvalon

The FDA has granted de novo regulatory approval to Pelvalon (Sunnyvale, CA) for its Eclipse vaginal insert for treating fecal incontinence. The choice of orifice may be a bit surprising, but the device works by exerting pressure on the rectum through the vaginal wall, just where a tampon is typically positioned, effectively closing off the rectum. When a trip to the bathroom is needed, the device is deflated and then re-inflated using an external pump.

The Eclipse is intiially fitted and inflated by a trained clinician, following which the patient can control it herself. There has not been anything quite like this on the market before, and though awkward may prove to be a popular drug-free solution for women struggling with bowel control. Interestingly, urinary incontinence was noted as a side effect.

From the FDA:

The FDA reviewed data for the Eclipse System through the de novo classification process, a regulatory pathway for some low-to-moderate risk medical devices that are not substantially equivalent to a legally marketed device.

The FDA granted the de novo request based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of FI episodes while using the device, as compared to baseline.

Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed).

Study of the Eclipse in journal Obstetrics & Gynecology: A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence.

Pelvalon homepage…

FDA: FDA permits marketing of fecal incontinence device for women

Pelvalon press release: FDA Approves Pelvalon’s Marketing Application for the Eclipse™ System, the First Vaginal Insert for Loss of Bowel Control

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

Sponsored
Venture builder BHV Partners launches Conus Airway to improve anaesthesia  and respiratory surgery

Venture builder BHV Partners launches Conus Airway to improve anaesthesia and respiratory surgery

FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

machineMD and Varjo revolutionize the diagnosis of brain disorders with a VR-based eye-tracking solution 

machineMD and Varjo revolutionize the diagnosis of brain disorders with a VR-based eye-tracking solution 

Ax-Surgi Hemostat gets FDA Clearance for Surgical Bleeding Control

Ax-Surgi Hemostat gets FDA Clearance for Surgical Bleeding Control

Clarius Report Finds 85% of Clinicians Believe Ultrasound Leads to Better Patient Outcomes

Clarius Report Finds 85% of Clinicians Believe Ultrasound Leads to Better Patient Outcomes

interviews & reviews
Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Imagene Profiles Cancer Biomarkers in Real Time

Imagene Profiles Cancer Biomarkers in Real Time

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Alpha TAU Killing Tumors With Highly Targeted Alpha Radiation

Alpha TAU Killing Tumors With Highly Targeted Alpha Radiation

Neuroimmune Modulation for Inflammatory Disease: Interview with Dr. Simhambhatla, President and CEO of SetPoint Medical

Neuroimmune Modulation for Inflammatory Disease: Interview with Dr. Simhambhatla, President and CEO of SetPoint Medical

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
Posting....
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email